FDA recall Z-0481-2025

Caire, Inc. · Class II · device

Product

CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.

Reason for recall

Potential failure of affected units to recharge the battery of the oxygen concentrators.

Distribution

Worldwide distribution - US Nationwide, including PR and the countries of Israel and Peru.

Key facts

Status
Completed
Initiation date
2024-10-04
Report date
2024-11-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Ball Ground, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0481-2025